Evaluation of Renastep

NCT03602937 | Completed

• 1 other identifier: MCT-RENS-2017-11-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will incorporate Renastep into their renal specific diet, during which time they will record gastrointestinal symptoms, adherence to recommended intakes and thoughts on its palatability. A Baseline CRF completed by the Investigator at the start of the trial will record demographic information, GI history and the most recent renal bio-marker results. Bio-marker results recorded as part of routine care over the course of the study will be captured in the End of Study CRF. The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS.

Conditions

Chronic Kidney Diseases; Renal Disease

Keywords

Acceptability; Renal; CKD; Kidney; Vitaflo; High energy, low volume; Low potassium; Low phosphorus; Low vitamin A

Outcome Measures

Primary Outcomes (5)

• Patients' compliance with recommended intakes of Renastep.

  Actual intake of the product will be compared with recommended intake. Participant to record how much of the product they took on each of the study days in a daily study dairy.

  Days 1 - 28.

• Patients' gastrointestinal tolerance of Renastep.

  Participant to record any gastrointestinal symptoms experienced in a daily study diary.

  Days 1 - 7.

• Patients' thoughts on Renastep's palatability

  Participants will rate Renastep's appearance, smell, taste, aftertaste, texture and presentation on a 5-point Likert scale at the end of their time on the study.

  Day 28.

• Patients' thoughts on Renastep's ease of use

  Participants will rate Renastep's ease of use on a 5-point likert scale at the end of their time on the study.

  Day 28.

• Nutritional suitability

  The product's nutritional suitability for use in a renal specific diet will be measured. The investigator will record the participant's most recent urea, phosphorus and potassium results (all mmo/L) taken as part of routine care prior to the intervention period beginning and all available results recorded as part of routine care over the course of the intervention period.

  Days 0 - 28

Study Arms (1)

Renastep

EXPERIMENTAL

All participants to incorporate Renastep into their usual dietary regime.

Dietary Supplement: Renastep

Interventions

Renastep DIETARY_SUPPLEMENT

Renastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption.

Renastep

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• i) Diagnosis of Chronic Kidney Disease.
• ii) Aged between 3 and 18 years.
• iii) Has a requirement for a restricted potassium and/or restricted phosphorus diet.
• iv) Has a requirement for nutrition support.
• v) Freely given, written, informed consent from patient or parent/guardian.
• vi) Freely given, written assent (if appropriate).

You may not qualify if:

• i) Inability to comply with the study protocol, in the opinion of the investigator.
• ii) Aged under 3 years or over 18 years.
• iii) Use of additional enteral feeds during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
• iv) Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

Study Sites (3)

Southampton Children's Hospital

Southampton, Hampshire, S016 6YD, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Birmingham Children's Hospital

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline Anderson

  University Hospital Southampton NHS Foundation Trust

  STUDY DIRECTOR

• Alison Holmes

  Alder Hey Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Sara Janes

  Birmingham Women's and Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label prospective acceptability study.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: July 27, 2018
• Study Start: April 17, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)